Acupuncture's increasingly widespread use has been paralleled by calls for more rigorous evidence of its effectiveness. In this article, some of the challenges of developing a strong evidence base are explored. As acupuncture is a complex intervention, a case is made for the appropriateness and relevance of pragmatic rather than experimental randomised controlled trials in the evaluation of acupuncture. Within this context there remain key challenges associated with ensuring treatment within a trial is sufficiently flexible, so that it can match the expected variability in patients, that outcomes measures capture the broader range of changes that can be experienced by patients, and that the therapeutic relationship is not compromised by the trial design. The central theme is the importance of protecting the integrity of the acupuncture, and the underlying principles upon which it is based.

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